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Pain | Association Between Body Size and Response to Hydromorphone in ED

Pain research study

What is the primary objective of this study?

Pain is the most common complaint for patients presenting to the emergency department (ED). Inadequate pain relief is also a common problem in ED. Patients' pain perceptions and responses to intravenous opioids vary widely and are influenced by multiple factors. The objective of the current study is to examine the association between total body weight, BMI (body mass index) and clinical response to a fixed dose of intravenous hydromorphone.

Who is eligible to participate?

Inclusion Criteria: - English or Spanish speaking - Age 18 - 65 years old - Acute pain (less than 7 days in duration) - Pain with sufficient severity to warrant use of intravenous opioids in the judgment of ED attending physician Exclusion Criteria: - Allergy to hydromorphone - Systolic blood pressure < 90 mm Hg - Room air oxygen saturation by pulse oximetry < 95% at baseline without supplemental oxygen - Alcohol or other drug intoxication as judged by the attending physician - Suspicion of drug seeking by ED physician - Use of opioids within the past 24 hours - Use of a monoamine oxidase inhibitor - Concurrent use of benzodiazepines - Presence of a chronic pain syndrome (such as sickle cell disease, peripheral neuropathy, diabetic neuropathy, or fibromyalgia) - History of COPD, sleep apnea, renal failure, liver disease - Pregnancy or breast feeding - Prior entry of patient in the study - Inability or unwillingness to provide informed consent

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Hydromorphonea fixed dose (1 mg) of hydromorphone will be given to the study subjects

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

HydromorphoneEvery enrolled patients will receive a fixed dose (1mg) of intravenous hydromorphone. Pain scale change, patients' satisfaction, requirements for additional pain medications, side effects and adverse events will be recorded at 15 and 30 minutes. Patients' weight and height will be measured. Age, gender, and race/ethnicity will also be recorded. Blood draw for genetic study will be performed.

Study Status

Unknown status

Start Date: October 2011

Completed Date: December 2012

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Association between pain scale change and TBW/BMI

Secondary Outcome: Association between change in pain at 15 minutes,

Study sponsors, principal investigator, and references

Principal Investigator: Adrienne Birnbaum, MD

Lead Sponsor: Albert Einstein College of Medicine, Inc.

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01675778

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